ISO 13485 medical quality system registration is an international standard adapted to meet the medical device industry’s requirements, and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused on ensuring medical devices safety and efficacy rather than enhancing customer satisfaction and continual improvement.
Appointing E& E Medicals as ISO Consultant
E & E Medicals and Consulting practices are based on assisting small, medium and large companies in the healthcare industry. All facilities that engage in the production, packaging and distribution of medical products need QMS for ISO 13485 certification. Achieving this objective needs your team to work with a competent ISO 13485 consultant. Our consultants provide detailed techniques on standards intent as ISO 13485 compliant Quality Management System (QMS) is implemented while creating confidence in end users, government, statutory and regulatory agencies with answers to all questions from Regulatory and Certification body auditors.
Medical Device Single Audit Program
The Medical Device Single Audit Program, commonly called MDSAP, is based on the principles of ISO 13485 medical quality system registration which remain a part of the audit requirements. Within the framework of the MDSAP, the quality management system of organizations can be audited for potentially five different markets (Canada, USA, Japan, Australia, and Brazil). It is important to know that, at a minimum, the provisions of ISO 13485 will be included in the audit criteria along with the relevant regulations for you to market your products in these countries.
Your organization will also meet most of the FDA requirements to have a Quality System in compliance with the QSRs set forth by 21CFR820. All Medical Device finished products and component manufactures, including Software and Medical Device Developers, have to meet ISO 13485 Certification requirements. ISO 13485 Certificate will be issued by an accredited third-party if you comply with the Medical Device Quality Management System. E & E Medicals and Consulting will assist in the training, documentation, implementation, internal audit, and other related services to ensure full compliance with the EN ISO 13485 medical quality system registration standard.